查看2014.Doxorubicin.HSA的源代码

=== AE 的评估、反应和结果 (Evaluation of AEs, response and outcome) ===

业主在每次就诊时完成书面问卷（图1），以报告胃肠道和其他不良事件。所有接受治疗的狗在每次使用 DOX 治疗之前都进行了 CBC，偶尔在治疗后 7 天进行。根据 VCOG-CTCAE 1.1.29 对治疗相关的 AE 进行分级

Owners completed written questionnaires (Fig. 1) at each visit to report gastrointestinal and other AEs. All treated dogs had a CBC performed before each treatment with DOX and occasionally at the 7-day mark after treatment. Treatment-related AEs were graded according to the VCOG-CTCAE 1.1.29


在每个治疗日和随访中对狗进行体格检查。所有接受 DOX 治疗的狗在第二次预定剂量的 DOX 之前立即接受了超声心动图的初步反应评估。根据 RECIST 1.1 指南30 进行反应评估，其中完全反应 （CR） 包括肿瘤完全消失;部分缓解 （PR） 包括最长肿瘤直径至少减少 30%;进行性疾病 （PD） 包括最长肿瘤直径至少增加 20%、出现转移性病变或提示疾病进展的临床体征（心包积液、腹腔积血和相关后遗症）;稳定疾病 （SD） 既没有充分的消退来符合 PR 的条件，也没有足够的进展来符合 PD 的条件。 建议在初始反应评估后每隔一次治疗就诊时进行超声心动图检查，以确认持续的反应并检测肿瘤进展。在第一次反应评估（第二次 DOX 剂量之前）检测到的 SD 必须至少持续到第二次反应评估时（每 2 次接受 DOX 的狗从治疗开始之日起 6 周，每 3 周接受一次 DOX 的狗从治疗开始之日起 9 周）才能被认为是真正的 SD。

Dogs were assessed with physical examinations on every treatment day and follow-up visit. All dogs receiving treatment with DOX underwent an initial response assessment with echocardiogram immediately before their second scheduled dose of DOX. Response assessment was made based on RECIST 1.1 guidelines,30 where complete response (CR) consisted of complete disappearance of the tumour; partial response (PR) consisted of at least a 30% reduction in longest tumour diameter; progressive disease (PD) consisted of at least a 20% increase in longest tumour diameter, the appearance of metastatic lesions, or clinical signs suggestive of disease progression (pericardial effusion, hemoperitoneum and related sequelae); and stable disease (SD) consisted of neither sufficient regression to qualify for PR nor sufficient progression to qualify for PD. Echocardiograms were recommended to be performed at every other treatment visit after the initial response assessment to confirm ongoing response and to detect tumour progression. SD detected at the first response assessment (before the second dose of DOX) had to be sustained at least until the time of the second response assessment (6 weeks from the time of treatment initiation in dogs receiving DOX every 2 and 9 weeks from treatment initiation for dogs receiving DOX every 3 weeks) in order to be considered true SD.


主要结局终点是PFS和总生存期（OS）。对所有接受至少一次 DOX 治疗的狗进行 PFS 评估，并计算从治疗开始到疾病进展或任何原因死亡的时间。如果狗在随访中丢失或在数据收集时没有疾病进展仍然活着，则从PFS分析中删失。对两个人群的OS进行了评估，并计算为从诊断到疾病进展死亡的时间。如果狗在随访中丢失，死于与肿瘤无关的原因，或者在数据收集时还活着，则从OS分析中剔除。

The primary outcome endpoints were PFS and overall survival (OS). PFS was assessed for all dogs receiving at least one DOX treatment session and was calculated as the time from treatment initiation to disease progression or death from any cause. Dogs were censored from PFS analysis if they were lost to follow-up or still alive without disease progression at the time of data collection. OS was assessed for both populations and was calculated as the time from diagnosis to death from disease progression. Dogs were censored from OS analysis if they were lost to follow-up, died from causes unrelated to the tumour, or were still alive at the time of data collection.

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